15 results
Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…
The primary objective of the study is to evaluate the safety and tolerability of the Occlutech® AFR device by assessing the incidence of SADEs in the 3 months following implantation. Secondary objectives are related to safety and efficacy:• To…
To establish whether niraparib single agent treatment in advanced BRCA1-like, HER2 negative breast cancer patients deserves to be further studied
Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib and Abiraterone Acetate co-administered as single agents at steady state under modified fasted conditions in…
Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) of niraparib plus pembrolizumab versus placebo…
The main objectives are to 1) investigate the relation between tau and amyloid accumulation in cognitively normal individuals, 2) test the contribution of genetic and non-genetic factors on tau binding in twins, and 3) test the relation of tau…
Primary objective:Evaulation of safety and tolerability of niraparibExploratory:Evaluation of the efficacy of niraparib relative to placebo as measured by disease-free survival (DFS)Evaluation of distant recurrence-free survival (DRFS)Time to first…
To 1) clinically validate the novel PET-tracer [18F]AV1451 for tau pathology as a diagnostic and prognostic marker in tauopathies, 2) to examine the (change in) (regional) binding of [18F]AV1451 across tauopathies, and the relationships between (…
Objectives: The primary objectives of this study are: • Part 1 (dose-escalation): To evaluate the safety of SYD985 in combination with niraparib to determine the maximum tolerated dose (MTD) and recommended combination dose regimen for expansion (…
Primary objective:- To assess the efficacy of niraparib in subjects with measurable mCRPC and who have either biallelic DNA-repair anomalies in BRCA (BRCA 1 and BRCA 2 or germline BRCA. Secondary objectives:- To assess the efficacy of niraparib in…
Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III or IV high-grade nonmucinous epithelial ovarian cancer treated with platinum-based combination therapy,…
The purpose of this study is to understand if a new treatment for prostate cancer (niraparib) added to a standard treatment (abiraterone acetate plus prednisone) will work better than the standard treatment alone.Cohort 3: the purpose is to evaluate…
The primary objective of this study is to determine the immune-activating capacity of treatment with pembrolizumab and carboplatin/paclitaxel in the neo-adjuvant setting of primary stage IV ovarian cancer as measured by the alteration in magnitude…
The objective of this study is to investigate whether an interatrial shunt device is superior to sham procedure in prevention of: (1) incidence of and time to cardiovascular mortality through 12-24 months; (2) incidence of and time to heart…
The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus prednisone) will work better than abiraterone acetate and prednisone alone in treating men with metastatic prostate cancer…